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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04436978
Other study ID # NL81102.100.22
Secondary ID 2022-001298-30
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 11, 2023
Est. completion date December 1, 2027

Study information

Verified date December 2023
Source St. Antonius Hospital
Contact Ashley Verburg, MD
Phone +31 (0)88 320 0925
Email as.verburg@antoniusziekenhuis.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. AF patients are treated with oral anticoagulation (OAC) to prevent ischemic stroke and systemic embolism and patients undergoing percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), i.e. aspirin plus P2Y12 inhibitor, to prevent stent thrombosis (ST) and myocardial infarction (MI). Patients with AF undergoing PCI were traditionally treated with triple antithrombotic therapy (TAT, i.e. OAC plus aspirin and P2Y12 inhibitor) to prevent ischemic complications. However, TAT doubles or even triples the risk of major bleeding complications. More recently, several clinical studies demonstrated that omitting aspirin, a strategy known as dual antithrombotic therapy (DAT) is safer compared to TAT with comparable efficacy. However, pooled evidence from recent meta-analyses suggests that patients treated with DAT are at increased risk of MI and ST. Insights from the AUGUSTUS trial showed that aspirin added to OAC and clopidogrel for 30 days, but not thereafter, resulted in fewer severe ischemic events. This finding emphasizes the relevance of early aspirin administration on ischemic benefit, also reflected in the current ESC guideline. However, because we consider the bleeding risk of TAT unacceptably high, we propose to use a short course of DAPT (omitting OAC for 1 month). There is evidence from the BRIDGE study that a short period of omitting OAC is safe in patients with AF. In this study, these patients are treated with DAPT, which also prevents stroke, albeit not as effective as OAC. This temporary interruption of OAC will allow aspirin treatment in the first month post-PCI where the risk of both bleeding and stent thrombosis is greatest. The WOEST 3 trial is a multicentre, open-label, randomised controlled trial investigating the safety and efficacy of one month DAPT compared to guideline-directed therapy consisting of OAC and P2Y12 inhibitor combined with aspirin up to 30 days. We hypothesise that the use of short course DAPT is superior in bleeding and non-inferior in preventing ischemic events. The primary safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI. The primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 1, 2027
Est. primary completion date October 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients = 18 years 2. Undergoing successful PCI (either ACS or elective PCI) 3. History of or newly diagnosed (<72 hours after PCI/ACS) atrial fibrillation or flutter with a long-term (= 1 year) indication for OAC Exclusion Criteria: 1. Contra indication to edoxaban, aspirin or all P2Y12 inhibitors 2. Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism) 3. <12 months after any stroke 4. CHADSVASc score =7 5. Moderate to severe mitral valve stenosis (AVA =1.5 cm2) 6. Mechanical heart valve prosthesis 7. Intracardiac thrombus or apical aneurysm requiring OAC 8. Poor LV function (LVEF <30%) with proven slow-flow 9. History of intracranial haemorrhage 10. Active bleeding on randomization 11. History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved 12. Recent (<1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved. 13. Known coagulopathy 14. Severe anaemia requiring blood transfusion or thrombocytopenia <50 × 109/L 15. BMI >40 or bariatric surgery 16. Kidney failure (eGFR <15) 17. Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C) 18. Active malignancy excluding non-melanoma skin cancer 19. Life expectancy <1 year 20. Pregnancy or breast-feeding women

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
30-day DAPT
DAPT (aspirin + P2Y12 inhibitor) during the first 30 days following PCI. After 30 days, all patients will be treated with edoxaban and a P2Y12 inhibitor.
Guideline-directed therapy
Guideline-directed therapy (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients)

Locations

Country Name City State
Belgium ASZ Aalst Aalst
Belgium UZ Antwerpen Antwerpen
Belgium Imelda Ziekenhuis Bonheiden
Belgium UZ Brussel Brussel
Belgium Ziekenhuis Oost-Limburg Genk
Belgium AZ Maria Middelares Gent Gent
Belgium Jan Yperman Ieper
Belgium AZ Groeninge Kortrijk
Belgium UZ Leuven Leuven
Belgium AZ Delta Roeselare
Netherlands Noordwest Ziekenhuisgroep Alkmaar
Netherlands Amsterdam UMC Amsterdam
Netherlands OLVG Amsterdam
Netherlands Hagaziekenhuis Den Haag
Netherlands Catharina Ziekenhuis Eindhoven
Netherlands Treant Zorggroep Emmen
Netherlands Zuyderland Ziekenhuis Heerlen
Netherlands Tergooi MC Hilversum
Netherlands St. Antonius Hospital Nieuwegein
Netherlands Elisabeth Tweesteden Ziekenhuis Tilburg

Sponsors (2)

Lead Sponsor Collaborator
St. Antonius Hospital Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of life as assessed by the EuroQol-5D-5L questionnaire EuroQol-5D-5L questionnaire 6 weeks, 3 months, 6 months
Primary Primary safety endpoint Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis 6 weeks
Primary Primary efficacy endpoint Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis 6 weeks
Secondary Bleeding complications Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis 6 months
Secondary Thrombotic complications Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis 6 months
Secondary Net clinical benefit Composite of major bleeding, myocardial infarction, stroke, systemic embolism all-cause death and stent thrombosis 6 weeks, 3 months, 6 months
Secondary Clinical symptom severity CCS grade 6 weeks, 3 months, 6 months
Secondary All-cause death All-cause death as defined by ARC-2 and SCTI 6 weeks, 3 months, 6 months
Secondary Myocardial infarction Myocardial infarction as defined by the 4th Universal Definition of Myocardial Infarction 6 weeks, 3 months, 6 months
Secondary Stroke Stroke as defined by VARC-2 definitions 6 weeks, 3 months, 6 months
Secondary Systemic embolism Systemic embolism according to ENTRUST-AF PCI definition 6 weeks, 3 months, 6 months
Secondary Stent thrombosis Stent thrombosis as defined by ARC-2 6 weeks, 3 months, 6 months
Secondary Major bleeding Major bleeding as defined by BARC 3 or 5 6 weeks, 3 months, 6 months
Secondary Clinically relevant non-major bleeding CRNM as defined by BARC 2 6 weeks, 3 months, 6 months
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